U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
데이터 추가 비고
Cement, bone, vertebroplasty - Product Code NDN
원인
Cement mixer used to prepare cement for surgery may not turn properly and may jam or stuck.
조치
DePuy Synthes Spine issued notification letter dated 1/11/13 issued via UPS Next Day Air Saver on 17 January 2013. Accounts requested to review inventory, quarantine any products listed in this recall notice and to complete and return the enclosed Business Reply Form. Contact the firm at 508-977-6606 for questions relating to this notice.
Worldwide Distribution-USA (nationwide) and the countries of Argentina, Armenia, Kazakhstan, Russia, Ukraine, Australia, Austria Belgium, Luxembourg , Brazil, Canada, China, Colombia, Cyprus, Jordan Lebanon, Saudi Arabia, UAE, Czech Republic, Finland ,France, Germany, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Latvia, Malaysia Mexico, Netherlands, New Zealand, Norway, Sweden, Poland, Portugal Singapore, Slovakia, Slovenia, South Africa, Spain, Switzerland, Turkey, and UK.
제품 설명
DePuy CONFIDENCE SPINAL CEMENT SYSTEM 7CC KIT || Catalog Number: 283907000. || Delivery of CONFIDENCE Spinal Cement, which is indicated for fixation of pathological fractures.